Monday, August 31, 2015

An article published yesterday at Inquisitr purports to present seven reasons why e-cigarettes are "bad."

Here they are:

1. The effects of e-cigarettes are nowhere near as well-documented as cigarettes.2. E-cigarettes contain plenty of cancerous chemicals.

3. E-cigarettes are just as addictive as smoking tobacco.

4. E-cigarettes have negative effects on lungs.

5. E-cigarettes won’t help you quit.6. E-cigarettes create the equivalent of secondhand smoke.7. E-cigarettes are a gateway into tobacco products for youth.

The Rest of the Story

The rest of the story is that most of these seven claims are false, all are misleading, all seven points actually demonstrate the public health value of e-cigarettes, and all seven arguments are taken almost verbatim from the propaganda being disseminated by colleagues of mine in the anti-smoking movement, demonstrating that their campaign of deception regarding e-cigarettes is working.

While the presence of this misleading information on one internet news site may not be terribly significant, the story is quite significant because it demonstrates that the false and deceptive information being disseminated by anti-smoking groups and health agencies which oppose e-cigarettes (including the CDC and the California Department of Public Health, as well as the American Lung Association) is being accepted at face value by the media and is therefore being spread to the public uncritically.

Here is the truth about each of the seven claims:

1. The effects of e-cigarettes are nowhere near as well-documented as cigarettes.

That's exactly the point! While cigarette smoke is known to contain more than 10,000 chemicals, including more than 60 known human carcinogens, and while smoking is known to kill hundreds of thousands of Americans each year from cancer, heart disease, emphysema, stroke, and numerous other diseases, electronic cigarette vapor has been documented to only produce a small number of chemicals, most at low levels, is not known to cause any major adverse health effects, and based on the existing studies, vaping is much safer than smoking, does not appear to cause any major acute problems, and at worst, may present mild risks if used regularly for many years. But those risks are certainly dwarfed by the risks of continuing to smoke. And, it is not yet clear whether vaping is a behavior that is likely to be maintained for decades, as we know smoking is.

So this argument is quite misleading, since it actually supports the idea that vaping is much safer than smoking and therefore, that smokers who are able to quit smoking by switching to e-cigarettes are doing themselves a great favor by substantially improving their health and perhaps saving their lives. In fact, several studies (not mentioned in the article and never cited by the anti-smoking groups which oppose e-cigarettes) document that smokers who switch to e-cigarettes experience an immediate improvement in their respiratory symptoms and lung function, including a reduction in airways resistance.

2. E-cigarettes contain plenty of cancerous chemicals.

So does city air. The issue is how the carcinogenic profile of e-cigarettes compares with that of tobacco cigarettes. We know conclusively that it is possible to produce e-cigarettes with no more than trace levels of any carcinogen, and several major brands of e-cigarettes (including those produced by the tobacco companies) have been documented not to contain no more than trace levels of any carcinogen. Even in e-cigarettes that have inadequate temperature regulation, there are only one or two carcinogens of concern (primarily formaldehyde), and it is not clear whether they confer any carcinogenic risk. Without a doubt, however, all of these products greatly lower a person's carcinogenic risk comparedto smoking.

3. E-cigarettes are just as addictive as smoking tobacco.

This is simply false. A number of studies have shown that e-cigarettes do not carry the same addictive power as tobacco cigarettes. The primary reason for this is that the nicotine delivery during vaping is much less effective than that during smoking.

4. E-cigarettes have negative effects on lungs.

It is not clear whether these "negative" effects have any clinical meaning. While vaping does lead to a slight increase in airways resistance, the changes are transient, and it is not clear whether there is any long-term risk. What is clear, however, is that switching from real cigarettes to e-cigarettes has almost immediate positive effects on respiratory function and health.

5. E-cigarettes won’t help you quit.This is also untrue. Electronic cigarettes have helped literally thousands of smokers in the U.S. quit successfully. Moreover, the long-term quit rates with electronic cigarettes - based on existing clinical trials - appear to be at least as high as with FDA-approved drugs.

6. E-cigarettes create the equivalent of secondhand smoke.

This is false. There is no smoke produced by e-cigarettes because there is no combustion. The "secondhand vapor" created by e-cigarettes (which is simply the exhaled air from the vaper) is much safer than secondhand smoke and it is not even clear that it poses any substantial health hazards to bystanders.

7. E-cigarettes are a gateway into tobacco products for youth.

This is also false. There is no evidence to support this claim, and all of the existing evidence points in the other direction, E-cigarettes are not a gateway into tobacco-containing products for youth and in fact, they appear to distract kids away from tobacco cigarette smoking by presenting a safer alternative.

Public Health Implications

Unfortunately, the public health implications of the campaign of deception being waged by e-cigarette opponents are quite negative. The campaign is undermining years of public education about the severe negative health impact of smoking. It is deceiving people into thinking that smoking is no more dangerous than using a non-tobacco-containing product which is not combusted. It is discouraging smokers who might otherwise have quit from even trying to quit. And it is causing many ex-smokers to return to smoking, thinking that there is no benefit to vaping over smoking so what's the point of remaining off of cigarettes.

Wednesday, August 19, 2015

A recent decision by a U.S. District Court (for the Southern District of New York) casts serious doubt on the constitutionality of the soon-to-be-released FDA deeming regulations for electronic cigarettes.

The ruling involved the question of whether drug companies may promote their products for off-label uses if such statements are factual and not misleading. The decision, explained in detail here, held that the FDA cannot prosecute a drug manufacturer for marketing a "misbranded" product based solely on the promotion of that drug for off-label purposes. The court ruled that such a prosecution would violate the First Amendment rights of the company, so long as it is making factual and non-misleading statements about the off-label uses.

Specifically, such a prosecution would not meet the third and fourth prongs of the Central Hudson test. First, it would not advance the government's interest in ensuring accurate communication to consumers because banning truthful, non-misleading statements does not advance such a purpose. Second, it violated the fourth prong of Central Hudson because the prohibition is far broader than necessary to advance the government's interest in ensuring that the information given to consumers about pharmaceutical products is accurate and non-misleading.

The Rest of the Story

This case has important potential implications for the e-cigarette deeming regulations that I expect the FDA to release shortly. Specifically, the case casts doubt on the constitutionality of what I expect will be the application of the modified risk provisions of the Family Smoking Prevention and Tobacco Control Act (section 911) to electronic cigarettes.

Should the FDA take such an action, it would mean that no electronic cigarette company could even mention to its customers that the product does not contain tobacco, or even that it does not produce smoke. Such statements would render the products to be "reduced exposure" products and would require pre-approval from the FDA. Section 911 clearly specifies that if a company suggests that its tobacco product does not produce a particular substance or is free of a substance contained in another tobacco product, then it is making a reduced exposure claim, which is not permissible without pre-approval.

Obtaining such approval would be impossible because the company would have to show that consumers do not infer that not containing tobacco or not producing smoke means that the product is likely safer than real tobacco cigarettes. Obviously, consumers are going to correctly infer that the absence of tobacco and combustion does indeed make e-cigarettes safer. Since these reduced exposure claims could never gain approval, the deeming regulations would essentially ban companies from making these truthful, non-misleading statements.

However, under the reasoning expounded in the New York district court decision, such a prohibition would likely be viewed as violating the free speech rights of the e-cigarette companies because it fails to satisfy the third and fourth prongs of Central Hudson. No government interest is advanced by forcing companies to essentially lie about the two most important features of their products: (1) the absence of tobacco; and (2) the absence of smoke (i.e., combustion). Prohibiting such truthful and non-misleading speech does nothing to advance the government's interest in ensuring that consumers receive accurate and non-misleading information about the safety or relative safety of different tobacco products.

In fact, such a prohibition would make it impossible for companies to truthfully and accurately communicate to consumers the relative safety of electronic cigarettes compared to tobacco cigarettes, which would essentially ensure that consumers are deeply misled about the relative safety of these two different types of "tobacco products." Thus, the prohibition not only fails to advance the government's purpose, but it directly contravenes that purpose. This would likely be viewed upon as a particularly unjustified intrusion into commercial free speech.

The rest of the story, then, is that I believe that the FDA's deeming regulations will be challenged successfully in court on the grounds that section 911, as applied to electronic cigarettes, infringes upon the free speech rights of electronic cigarette companies.

Tuesday, August 18, 2015

A new study published moments ago in JAMA reports the results of a one-year longitudinal follow-up study of 9th graders in Los Angeles schools who did not smoke cigarettes at baseline. Among the 9th grade students who had ever tried an electronic cigarette at baseline, the odds of progression to smoking initiation were 2.7 times higher than among students who had never tried an electronic cigarette. Importantly, the study defined smoking initiation as any cigarette use (even just a single puff).

(See: Leventhal AM, et al. Association of electronic cigarette use with initiation of combustible tobacco product smoking in early adolescence. JAMA. Published online ahead of print on August 18, 2015.)

Within hours of the release of the JAMA study, the Campaign for Tobacco-Free Kids issued a press release arguing that these data suggest e-cigarette use is "a gateway to use of other tobacco products, including regular cigarettes" and that "use of electronic cigarettes by youth who had not previously smoked could lead to use of cigarettes. ..."

The press release closes by stating: "We cannot allow the tobacco industry to keep addicting kids and create
another epidemic with a new generation of tobacco products."

The Rest of the Story

The rest of the story is that the Campaign for Tobacco-Free Kids is being too hasty in jumping on this study as providing evidence that e-cigarettes are a gateway to smoking. The study shows nothing of the sort, and the authors and commentators readily acknowledge that. Apparently, the Campaign is so anxious to demonize e-cigarettes and to support its pre-determined conclusions that it is willing to throw rigorous scientific analysis out the window when it sees an opportunity to pounce on a good headline.

There are three huge limitations of the study which make it essentially irrelevant to the question of whether e-cigarette use leads kids to start smoking. First, the study did not measure "e-cigarette use." It merely asked kids whether they had "ever" tried an e-cigarette. Kids who had ever tried an e-cigarette, even a puff, where compared with all kids who had never even puffed on an e-cigarette.

You can immediately see the problem here. Kids who would not even try an e-cigarette, despite their popularity, represent a different population than kids who would try a puff on an e-cig. Of course the subsequent smoking rates are going to be higher among the kids who were susceptible to trying the e-cigarette. There is really no news here. This is a phenomenon which has already been documented in the literature.

The second problem is that the study failed to document that any of these kids actually used e-cigarettes regularly and became addicted to them before proceeding to use real cigarettes. All the study documented is that these kids had tried e-cigarettes at least once. The study simply cannot infer that these students became regular users of e-cigarettes, that they became addicted to e-cigarettes, or even that they ever tried an e-cigarette again.

Third, the study defined smoking as any use of a cigarette, even a puff. Thus, even among the youth who supposedly initiated smoking, we don't know that they actually became smokers. They may simply have tried a puff on a cigarette and decided it was not for them. In fact, it is entirely possible that they tried a puff on a cigarette, decided that the e-cigarette was much better tasting, and that they chose to vape instead of smoke. In this way, e-cigarettes could have actually served as a deterrent to smoking among this population.

Ultimately, what this research demonstrates is that youth who experiment with electronic cigarettes represent a sub-population of youth which is at increased risk of tobacco product use. This is a natural finding that we expected to be true and which has been documented in other studies. The study does not show that e-cigarette use leads kids to start smoking or to become regular smokers. It does not demonstrate a gateway effect.

The study authors readily acknowledge this, with the lead author making it clear that: "we cannot conclude that e-cigarette use directly leads to smoking."

The accompanying editorial makes the same point, even more clearly: "Because the only outcome measure was any use of a tobacco product during the past 6 months, the analysis could not distinguish students who had just tried a few cigarettes from those who progressed to regular smoking during follow-up. The latter is the greater concern, and the current study cannot determine whether e-cigarette exposure was associated with that outcome."

Nevertheless, these cautions did not prevent the Campaign for Tobacco-Free Kids to draw its own conclusion - apparently a pre-determined one - that e-cigarettes are leading youth to try real cigarettes and to become addicted to them. Apparently, the Campaign for Tobacco-Free Kids doesn't need actual evidence to draw scientific conclusions; it just needs any potential headline that it can pounce on. That's exactly how I would describe the tobacco industry's behavior historically.

To make matters worse, the Campaign for Tobacco-Free Kids misleads the public by calling e-cigarettes "tobacco products," despite the fact that they contain no tobacco. And, it attacks the tobacco companies for addicting kids to e-cigarettes when it is not even clear whether or not any nonsmoking youth are addicted to e-cigarettes and if any are, it is not clear that any tobacco company e-cigarette brands are involved. After all, maybe it is the "gummy bear and cotton candy" brands (not manufactured by Big Tobacco) which are the ones implicated in the rapidly increasing rates of smoking that have been observed among America's youth contemporaneously with the dramatic rise in e-cigarette experimentation.

Check that. There are no rapidly increasing rates of smoking that have been observed among
America's youth contemporaneously with the dramatic rise in e-cigarette
experimentation. It is rapidly decreasing rates of smoking.

Monday, August 17, 2015

According to a public health official in Indiana, it is just as safe to smoke a cigarette as it is to vape an electronic cigarette.

According to an article in the South Bend Tribune, the executive director of the Indiana Prevention Resource Center stated: "What we can gather is that students have this misconception it’s
somehow safer than smoking a cigarette. I think the
tobacco industry is really intentionally marketing e-cigarettes that way
to make them appear, kind of by implication, that they’re safer than
smoking a cigarette."

The statement was made in the context of the release of a new survey, which showed that despite widespread use of electronic cigarettes among Indiana teenagers, fewer and fewer teens are smoking tobacco cigarettes.

According to the Indiana Youth Survey, as many as one-fourth of all high school seniors in Indiana were "current users" of electronic cigarettes in 2015, defined as having used electronic cigarettes at least once in the past 30 days. Despite this high prevalence of e-cigarette use, the proportion of high school seniors who reported smoking dropped from 17.6% in 2014 to 16.2% in 2015.

In fact, the rapid proliferation of electronic cigarette use among youth in Indiana, which occurred chiefly between 2011 and 2015, coincided with a dramatic decline in smoking during the same period. Smoking among high school seniors in Indiana, for example, declined from 24.6% in 2011 to 16.2% in 2015, about a 33% reduction. Prior to 2011, smoking had not declined at all during the previous four years.

The Rest of the Story

The Indiana Youth Survey adds to the evidence that e-cigarettes are not serving as any major gateway to cigarette smoking among youth. With experimentation rates as high as 25% among high school seniors, it is just not consistent with the gateway hypothesis that we would continue to see dramatically declining smoking prevalence in the face of this massive experimentation with e-cigarettes if e-cigarette experimentation were truly serving as a gateway to cigarette smoking.

But the real story here is not merely the release of these new data. The real story is that this is another example of public health officials lying to the public about the relative health effects of smoking compared to vaping. Here, the Indiana Prevention Resource Center is telling the public that smoking cigarettes is every bit as safe as experimenting with e-cigarettes. In fact, the Center actually bemoans the fact that fewer kids are smoking cigarettes than experimenting with e-cigarettes. It appears that the Center would have been more pleased had the smoking rate not dropped so much, but had there been very low rates of e-cigarette use.

Is this about public health anymore, or is there some other ideological goal that I was not told about during my masters in public health training? It appears, in fact, that we are now pursuing the isolated ideological goal of conquering nicotine addiction rather than the effort to try to save lives and improve the public's health. We've reached that point. When we actually want to see more kids smoking than using a relatively benign form of nicotine instead, then we know we're no longer in public health, but in the realm of pursuing ideology.

The worst part of the story, however, is the fact that we are apparently OK with lying to the public in order to pursue even this ideological and misguided goal. The truth no longer matters to us. Conveying accurate information to the public no longer matters.

Ironically, if the tobacco companies were making precisely the same claims as the Indiana Prevention Resource Center (i.e., that smoking is no more dangerous than vaping), you can be sure that anti-smoking groups around the country would be vigorously attacking Big Tobacco for lying to the public and undermining the public's appreciation of the hazards of smoking. But when it's us doing the lying, apparently it's acceptable, as long as our ultimate end is a good one (and in this case, it's not even a good end!).

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.